Home NDC 0006-3080 ISENTRESS
Product NDC 0006-3080
11-digit product format 000063080
Labeler code 0006
Product ID 0006-3080_70b9b593-db43-43ad-8808-a1c86c048145
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name RALTEGRAVIR
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Merck Sharp & Dohme LLC
Application NDA022145
Marketing category NDA
Marketing start 2017-05-26
Substance RALTEGRAVIR POTASSIUM
Active strength 600 mg/1
Pharmacologic classes HIV Integrase Inhibitors [MoA], Human Immunodeficiency Virus Integrase Strand Transfer Inhibitor [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N022145-001 ISENTRESS RALTEGRAVIR POTASSIUM EQ 400MG BASE TABLET / ORAL RLD, RS 2007-10-12 N022145-002 ISENTRESS HD RALTEGRAVIR POTASSIUM EQ 600MG BASE TABLET / ORAL AB RLD, RS 2017-05-26
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N022145-002 AB
Orange Book patents# Current patent rows page 1 of 1 · 10 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N022145-001 8852632 2028-01-28 U-257 Drug substance, Drug product 2023-03-27 N022145-001 7754731 2029-03-11 U-257 Drug substance, Drug product N022145-001 7754731*PED 2029-09-11 Pediatric extension N022145-001 8771733 2030-06-02 U-257 Drug substance, Drug product 2023-03-27 N022145-002 7754731 2029-03-11 U-257 Drug substance, Drug product 2017-06-23 N022145-002 7754731*PED 2029-09-11 Pediatric extension N022145-002 8771733 2030-06-02 U-257 Drug substance, Drug product 2023-03-27 N022145-002 9649311 2030-10-21 Drug product 2017-06-23 N022145-002 9649311*PED 2031-04-21 Pediatric extension N022145-002 10772888 2032-03-30 U-1663 2020-10-27
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 3 · 84 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 N022145-001 ISENTRESS EQ 400MG BASE TABLET / ORAL RLD, RS 2007-10-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022145-002 ISENTRESS HD EQ 600MG BASE TABLET / ORAL AB RLD, RS 2017-05-26 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N022145-001 ISENTRESS EQ 400MG BASE TABLET / ORAL RLD, RS 2007-10-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022145-002 ISENTRESS HD EQ 600MG BASE TABLET / ORAL AB RLD, RS 2017-05-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022145-001 ISENTRESS EQ 400MG BASE TABLET / ORAL RLD, RS 2007-10-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022145-002 ISENTRESS HD EQ 600MG BASE TABLET / ORAL AB RLD, RS 2017-05-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022145-001 ISENTRESS EQ 400MG BASE TABLET / ORAL RLD, RS 2007-10-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022145-002 ISENTRESS HD EQ 600MG BASE TABLET / ORAL AB RLD, RS 2017-05-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022145-001 ISENTRESS EQ 400MG BASE TABLET / ORAL RLD, RS 2007-10-12 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022145-002 ISENTRESS HD EQ 600MG BASE TABLET / ORAL RLD, RS 2017-05-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022145-001 ISENTRESS EQ 400MG BASE TABLET / ORAL RLD, RS 2007-10-12 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022145-002 ISENTRESS HD EQ 600MG BASE TABLET / ORAL RLD, RS 2017-05-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022145-001 ISENTRESS EQ 400MG BASE TABLET / ORAL AB RLD, RS 2007-10-12 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022145-002 ISENTRESS HD EQ 600MG BASE TABLET / ORAL RLD, RS 2017-05-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022145-001 ISENTRESS EQ 400MG BASE TABLET / ORAL RLD, RS 2007-10-12 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022145-002 ISENTRESS HD EQ 600MG BASE TABLET / ORAL RLD, RS 2017-05-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022145-001 ISENTRESS EQ 400MG BASE TABLET / ORAL RLD, RS 2007-10-12 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022145-002 ISENTRESS HD EQ 600MG BASE TABLET / ORAL RLD, RS 2017-05-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022145-001 ISENTRESS EQ 400MG BASE TABLET / ORAL RLD, RS 2007-10-12 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022145-002 ISENTRESS HD EQ 600MG BASE TABLET / ORAL RLD, RS 2017-05-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022145-001 ISENTRESS EQ 400MG BASE TABLET / ORAL RLD, RS 2007-10-12 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N022145-002 ISENTRESS HD EQ 600MG BASE TABLET / ORAL RLD, RS 2017-05-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022145-001 ISENTRESS EQ 400MG BASE TABLET / ORAL RLD, RS 2007-10-12 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022145-002 ISENTRESS HD EQ 600MG BASE TABLET / ORAL RLD, RS 2017-05-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022145-001 ISENTRESS EQ 400MG BASE TABLET / ORAL RLD, RS 2007-10-12 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022145-002 ISENTRESS HD EQ 600MG BASE TABLET / ORAL RLD, RS 2017-05-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022145-001 ISENTRESS EQ 400MG BASE TABLET / ORAL RLD, RS 2007-10-12 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022145-002 ISENTRESS HD EQ 600MG BASE TABLET / ORAL RLD, RS 2017-05-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N022145-001 ISENTRESS EQ 400MG BASE TABLET / ORAL RLD, RS 2007-10-12 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N022145-002 ISENTRESS HD EQ 600MG BASE TABLET / ORAL RLD, RS 2017-05-26 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022145-001 ISENTRESS EQ 400MG BASE TABLET / ORAL RLD, RS 2007-10-12 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022145-002 ISENTRESS HD EQ 600MG BASE TABLET / ORAL RLD, RS 2017-05-26 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N022145-001 ISENTRESS EQ 400MG BASE TABLET / ORAL RLD, RS 2007-10-12 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022145-002 ISENTRESS HD EQ 600MG BASE TABLET / ORAL RLD, RS 2017-05-26 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N022145-001 ISENTRESS EQ 400MG BASE TABLET / ORAL RLD, RS 2007-10-12 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N022145-002 ISENTRESS HD EQ 600MG BASE TABLET / ORAL RLD, RS 2017-05-26 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N022145-001 ISENTRESS EQ 400MG BASE TABLET / ORAL RLD, RS 2007-10-12 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022145-002 ISENTRESS HD EQ 600MG BASE TABLET / ORAL RLD, RS 2017-05-26 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N022145-001 ISENTRESS EQ 400MG BASE TABLET / ORAL RLD, RS 2007-10-12 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N022145-002 ISENTRESS HD EQ 600MG BASE TABLET / ORAL RLD, RS 2017-05-26 bb7c543d1eb4…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Patent history page 1 of 18 · 684 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-18 06:07:40 2026-07 N022145-001 8852632 2028-01-28 U-257 Drug substance, Drug product 2023-03-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022145-001 7754731 2029-03-11 U-257 Drug substance, Drug product caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022145-001 7754731*PED 2029-09-11 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022145-001 8771733 2030-06-02 U-257 Drug substance, Drug product 2023-03-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022145-002 7754731 2029-03-11 U-257 Drug substance, Drug product 2017-06-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022145-002 7754731*PED 2029-09-11 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022145-002 8771733 2030-06-02 U-257 Drug substance, Drug product 2023-03-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022145-002 9649311 2030-10-21 Drug product 2017-06-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022145-002 9649311*PED 2031-04-21 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022145-002 10772888 2032-03-30 U-1663 2020-10-27 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N022145-001 8852632 2028-01-28 U-257 Drug substance, Drug product 2023-03-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022145-001 7754731 2029-03-11 U-257 Drug substance, Drug product 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022145-001 7754731*PED 2029-09-11 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022145-001 8771733 2030-06-02 U-257 Drug substance, Drug product 2023-03-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022145-002 7754731 2029-03-11 U-257 Drug substance, Drug product 2017-06-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022145-002 7754731*PED 2029-09-11 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022145-002 8771733 2030-06-02 U-257 Drug substance, Drug product 2023-03-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022145-002 9649311 2030-10-21 Drug product 2017-06-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022145-002 9649311*PED 2031-04-21 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022145-002 10772888 2032-03-30 U-1663 2020-10-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022145-001 8852632 2028-01-28 U-257 Drug substance, Drug product 2023-03-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022145-001 7754731 2029-03-11 U-257 Drug substance, Drug product 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022145-001 7754731*PED 2029-09-11 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022145-001 8771733 2030-06-02 U-257 Drug substance, Drug product 2023-03-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022145-002 7754731 2029-03-11 U-257 Drug substance, Drug product 2017-06-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022145-002 7754731*PED 2029-09-11 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022145-002 8771733 2030-06-02 U-257 Drug substance, Drug product 2023-03-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022145-002 9649311 2030-10-21 Drug product 2017-06-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022145-002 9649311*PED 2031-04-21 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022145-002 10772888 2032-03-30 U-1663 2020-10-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022145-001 8852632 2028-01-28 U-257 Drug substance, Drug product 2023-03-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022145-001 7754731 2029-03-11 U-257 Drug substance, Drug product 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022145-001 7754731*PED 2029-09-11 Pediatric extension 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022145-001 8771733 2030-06-02 U-257 Drug substance, Drug product 2023-03-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022145-002 7754731 2029-03-11 U-257 Drug substance, Drug product 2017-06-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022145-002 7754731*PED 2029-09-11 Pediatric extension 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022145-002 8771733 2030-06-02 U-257 Drug substance, Drug product 2023-03-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022145-002 9649311 2030-10-21 Drug product 2017-06-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022145-002 9649311*PED 2031-04-21 Pediatric extension 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022145-002 10772888 2032-03-30 U-1663 2020-10-27 6a471c1ec25d…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 54 observed states.
Additional Listing Data#
Finished product Yes
Brand name base ISENTRESS
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength RALTEGRAVIR POTASSIUM 600 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 43Y000U234 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 10 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 744842 Internal RxNorm lookup 744846 Internal RxNorm lookup 1235588 Internal RxNorm lookup 1235591 Internal RxNorm lookup 1235593 Internal RxNorm lookup 1235595 Internal RxNorm lookup 1486838 Internal RxNorm lookup 1486841 Internal RxNorm lookup 1924313 Internal RxNorm lookup 1924315 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0006-3080-01 ISENTRESS 60 in 1 BOTTLE TABLET, FILM COATED 60 70
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded RALTEGRAVIR POTASSIUM ACTIVE INGREDIENT 43Y000U234 ISENTRESS (RALTEGRAVIR) TABLET, FILM COATED ISENTRESS (RALTEGRAVIR) TABLET, CHEWABLE ISENTRESS (RALTEGRAVIR) GRANULE, FOR SUSPENSION [MERCK SHARP & DOHME CORP.] 49 RALTEGRAVIR ACTIVE MOIETY 22VKV8053U ISENTRESS (RALTEGRAVIR) TABLET, FILM COATED ISENTRESS (RALTEGRAVIR) TABLET, CHEWABLE ISENTRESS (RALTEGRAVIR) GRANULE, FOR SUSPENSION [MERCK SHARP & DOHME CORP.] 49 AMMONIA INACTIVE INGREDIENT 5138Q19F1X ISENTRESS (RALTEGRAVIR) TABLET, FILM COATED ISENTRESS (RALTEGRAVIR) TABLET, CHEWABLE ISENTRESS (RALTEGRAVIR) GRANULE, FOR SUSPENSION [MERCK SHARP & DOHME CORP.] 49 AMMONIUM GLYCYRRHIZATE INACTIVE INGREDIENT 3VRD35U26C ISENTRESS (RALTEGRAVIR) TABLET, FILM COATED ISENTRESS (RALTEGRAVIR) TABLET, CHEWABLE ISENTRESS (RALTEGRAVIR) GRANULE, FOR SUSPENSION [MERCK SHARP & DOHME CORP.] 49 ASPARTAME INACTIVE INGREDIENT Z0H242BBR1 ISENTRESS (RALTEGRAVIR) TABLET, FILM COATED ISENTRESS (RALTEGRAVIR) TABLET, CHEWABLE ISENTRESS (RALTEGRAVIR) GRANULE, FOR SUSPENSION [MERCK SHARP & DOHME CORP.] 49 BUTYLATED HYDROXYTOLUENE INACTIVE INGREDIENT 1P9D0Z171K ISENTRESS (RALTEGRAVIR) TABLET, FILM COATED ISENTRESS (RALTEGRAVIR) TABLET, CHEWABLE ISENTRESS (RALTEGRAVIR) GRANULE, FOR SUSPENSION [MERCK SHARP & DOHME CORP.] 49 CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS INACTIVE INGREDIENT L11K75P92J ISENTRESS (RALTEGRAVIR) TABLET, FILM COATED ISENTRESS (RALTEGRAVIR) TABLET, CHEWABLE ISENTRESS (RALTEGRAVIR) GRANULE, FOR SUSPENSION [MERCK SHARP & DOHME CORP.] 49 carboxymethylcellulose sodium INACTIVE INGREDIENT K679OBS311 ISENTRESS (RALTEGRAVIR) TABLET, FILM COATED ISENTRESS (RALTEGRAVIR) TABLET, CHEWABLE ISENTRESS (RALTEGRAVIR) GRANULE, FOR SUSPENSION [MERCK SHARP & DOHME CORP.] 49 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U ISENTRESS (RALTEGRAVIR) TABLET, FILM COATED ISENTRESS (RALTEGRAVIR) TABLET, CHEWABLE ISENTRESS (RALTEGRAVIR) GRANULE, FOR SUSPENSION [MERCK SHARP & DOHME CORP.] 49 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK ISENTRESS (RALTEGRAVIR) TABLET, FILM COATED ISENTRESS (RALTEGRAVIR) TABLET, CHEWABLE ISENTRESS (RALTEGRAVIR) GRANULE, FOR SUSPENSION [MERCK SHARP & DOHME CORP.] 49 ETHYLCELLULOSE (20 MPA.S) INACTIVE INGREDIENT BJG0S321QY ISENTRESS (RALTEGRAVIR) TABLET, FILM COATED ISENTRESS (RALTEGRAVIR) TABLET, CHEWABLE ISENTRESS (RALTEGRAVIR) GRANULE, FOR SUSPENSION [MERCK SHARP & DOHME CORP.] 49 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 ISENTRESS (RALTEGRAVIR) TABLET, FILM COATED ISENTRESS (RALTEGRAVIR) TABLET, CHEWABLE ISENTRESS (RALTEGRAVIR) GRANULE, FOR SUSPENSION [MERCK SHARP & DOHME CORP.] 49 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT ISENTRESS (RALTEGRAVIR) TABLET, FILM COATED ISENTRESS (RALTEGRAVIR) TABLET, CHEWABLE ISENTRESS (RALTEGRAVIR) GRANULE, FOR SUSPENSION [MERCK SHARP & DOHME CORP.] 49 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 ISENTRESS (RALTEGRAVIR) TABLET, FILM COATED ISENTRESS (RALTEGRAVIR) TABLET, CHEWABLE ISENTRESS (RALTEGRAVIR) GRANULE, FOR SUSPENSION [MERCK SHARP & DOHME CORP.] 49 FRUCTOSE INACTIVE INGREDIENT 6YSS42VSEV ISENTRESS (RALTEGRAVIR) TABLET, FILM COATED ISENTRESS (RALTEGRAVIR) TABLET, CHEWABLE ISENTRESS (RALTEGRAVIR) GRANULE, FOR SUSPENSION [MERCK SHARP & DOHME CORP.] 49 HYDROXYPROPYL CELLULOSE (TYPE H) INACTIVE INGREDIENT RFW2ET671P ISENTRESS (RALTEGRAVIR) TABLET, FILM COATED ISENTRESS (RALTEGRAVIR) TABLET, CHEWABLE ISENTRESS (RALTEGRAVIR) GRANULE, FOR SUSPENSION [MERCK SHARP & DOHME CORP.] 49 HYPROMELLOSE 2910 (6 MPA.S) INACTIVE INGREDIENT 0WZ8WG20P6 ISENTRESS (RALTEGRAVIR) TABLET, FILM COATED ISENTRESS (RALTEGRAVIR) TABLET, CHEWABLE ISENTRESS (RALTEGRAVIR) GRANULE, FOR SUSPENSION [MERCK SHARP & DOHME CORP.] 49 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO ISENTRESS (RALTEGRAVIR) TABLET, FILM COATED ISENTRESS (RALTEGRAVIR) TABLET, CHEWABLE ISENTRESS (RALTEGRAVIR) GRANULE, FOR SUSPENSION [MERCK SHARP & DOHME CORP.] 49 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X ISENTRESS (RALTEGRAVIR) TABLET, FILM COATED ISENTRESS (RALTEGRAVIR) TABLET, CHEWABLE ISENTRESS (RALTEGRAVIR) GRANULE, FOR SUSPENSION [MERCK SHARP & DOHME CORP.] 49 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 ISENTRESS (RALTEGRAVIR) TABLET, FILM COATED ISENTRESS (RALTEGRAVIR) TABLET, CHEWABLE ISENTRESS (RALTEGRAVIR) GRANULE, FOR SUSPENSION [MERCK SHARP & DOHME CORP.] 49 MALTODEXTRIN INACTIVE INGREDIENT 7CVR7L4A2D ISENTRESS (RALTEGRAVIR) TABLET, FILM COATED ISENTRESS (RALTEGRAVIR) TABLET, CHEWABLE ISENTRESS (RALTEGRAVIR) GRANULE, FOR SUSPENSION [MERCK SHARP & DOHME CORP.] 49 MANNITOL INACTIVE INGREDIENT 3OWL53L36A ISENTRESS (RALTEGRAVIR) TABLET, FILM COATED ISENTRESS (RALTEGRAVIR) TABLET, CHEWABLE ISENTRESS (RALTEGRAVIR) GRANULE, FOR SUSPENSION [MERCK SHARP & DOHME CORP.] 49 MEDIUM-CHAIN TRIGLYCERIDES INACTIVE INGREDIENT C9H2L21V7U ISENTRESS (RALTEGRAVIR) TABLET, FILM COATED ISENTRESS (RALTEGRAVIR) TABLET, CHEWABLE ISENTRESS (RALTEGRAVIR) GRANULE, FOR SUSPENSION [MERCK SHARP & DOHME CORP.] 49 OLEIC ACID INACTIVE INGREDIENT 2UMI9U37CP ISENTRESS (RALTEGRAVIR) TABLET, FILM COATED ISENTRESS (RALTEGRAVIR) TABLET, CHEWABLE ISENTRESS (RALTEGRAVIR) GRANULE, FOR SUSPENSION [MERCK SHARP & DOHME CORP.] 49 POLOXAMER 407 INACTIVE INGREDIENT TUF2IVW3M2 ISENTRESS (RALTEGRAVIR) TABLET, FILM COATED ISENTRESS (RALTEGRAVIR) TABLET, CHEWABLE ISENTRESS (RALTEGRAVIR) GRANULE, FOR SUSPENSION [MERCK SHARP & DOHME CORP.] 49 POLYETHYLENE GLYCOL 3350 INACTIVE INGREDIENT G2M7P15E5P ISENTRESS (RALTEGRAVIR) TABLET, FILM COATED ISENTRESS (RALTEGRAVIR) TABLET, CHEWABLE ISENTRESS (RALTEGRAVIR) GRANULE, FOR SUSPENSION [MERCK SHARP & DOHME CORP.] 49 POLYETHYLENE GLYCOL 400 INACTIVE INGREDIENT B697894SGQ ISENTRESS (RALTEGRAVIR) TABLET, FILM COATED ISENTRESS (RALTEGRAVIR) TABLET, CHEWABLE ISENTRESS (RALTEGRAVIR) GRANULE, FOR SUSPENSION [MERCK SHARP & DOHME CORP.] 49 POLYVINYL ALCOHOL INACTIVE INGREDIENT 532B59J990 ISENTRESS (RALTEGRAVIR) TABLET, FILM COATED ISENTRESS (RALTEGRAVIR) TABLET, CHEWABLE ISENTRESS (RALTEGRAVIR) GRANULE, FOR SUSPENSION [MERCK SHARP & DOHME CORP.] 49 SACCHARIN SODIUM INACTIVE INGREDIENT SB8ZUX40TY ISENTRESS (RALTEGRAVIR) TABLET, FILM COATED ISENTRESS (RALTEGRAVIR) TABLET, CHEWABLE ISENTRESS (RALTEGRAVIR) GRANULE, FOR SUSPENSION [MERCK SHARP & DOHME CORP.] 49 SODIUM STEARYL FUMARATE INACTIVE INGREDIENT 7CV7WJK4UI ISENTRESS (RALTEGRAVIR) TABLET, FILM COATED ISENTRESS (RALTEGRAVIR) TABLET, CHEWABLE ISENTRESS (RALTEGRAVIR) GRANULE, FOR SUSPENSION [MERCK SHARP & DOHME CORP.] 49 SORBITOL INACTIVE INGREDIENT 506T60A25R ISENTRESS (RALTEGRAVIR) TABLET, FILM COATED ISENTRESS (RALTEGRAVIR) TABLET, CHEWABLE ISENTRESS (RALTEGRAVIR) GRANULE, FOR SUSPENSION [MERCK SHARP & DOHME CORP.] 49 SUCRALOSE INACTIVE INGREDIENT 96K6UQ3ZD4 ISENTRESS (RALTEGRAVIR) TABLET, FILM COATED ISENTRESS (RALTEGRAVIR) TABLET, CHEWABLE ISENTRESS (RALTEGRAVIR) GRANULE, FOR SUSPENSION [MERCK SHARP & DOHME CORP.] 49 SUCROSE INACTIVE INGREDIENT C151H8M554 ISENTRESS (RALTEGRAVIR) TABLET, FILM COATED ISENTRESS (RALTEGRAVIR) TABLET, CHEWABLE ISENTRESS (RALTEGRAVIR) GRANULE, FOR SUSPENSION [MERCK SHARP & DOHME CORP.] 49 TALC INACTIVE INGREDIENT 7SEV7J4R1U ISENTRESS (RALTEGRAVIR) TABLET, FILM COATED ISENTRESS (RALTEGRAVIR) TABLET, CHEWABLE ISENTRESS (RALTEGRAVIR) GRANULE, FOR SUSPENSION [MERCK SHARP & DOHME CORP.] 49 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP ISENTRESS (RALTEGRAVIR) TABLET, FILM COATED ISENTRESS (RALTEGRAVIR) TABLET, CHEWABLE ISENTRESS (RALTEGRAVIR) GRANULE, FOR SUSPENSION [MERCK SHARP & DOHME CORP.] 49 TRISODIUM CITRATE DIHYDRATE INACTIVE INGREDIENT B22547B95K ISENTRESS (RALTEGRAVIR) TABLET, FILM COATED ISENTRESS (RALTEGRAVIR) TABLET, CHEWABLE ISENTRESS (RALTEGRAVIR) GRANULE, FOR SUSPENSION [MERCK SHARP & DOHME CORP.] 49
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0006-3080 ISENTRESS (RALTEGRAVIR) TABLET, FILM COATED ISENTRESS (RALTEGRAVIR) TABLET, CHEWABLE ISENTRESS (RALTEGRAVIR) GRANULE, FOR SUSPENSION [MERCK SHARP & DOHME LLC] 69 Current NDC, Legacy NDC, 1 package rows 20241030_89a5ec53-d956-4329-8004-0f40f51c88a3.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 4 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0006-3080-01 00006308001 60 TABLET, FILM COATED in 1 BOTTLE (0006-3080-01) 2017-05-26 0000-00-00 No No Current